1. Field of the Invention
This invention relates to providing a custom ankle brace system. More particularly, this invention concerns such a system for being of help to patients whose ankle conditions are of certain types and no longer permit them to walk properly without some sort of custom orthotic.
2. Description of the Prior Art
Typically, individuals suffer from certain conditions of the feet which either greatly limit unaided mobility or require the use of aids such as walkers or canes in order for the individual to be mobile. Conditions which may cause this debilitating condition include tibialis tendinitis or rupture, degenerate joint disease, talocalcaneal varus or valgus, severe pronation, and/or trauma to ankle, subtalar, or midtarsal. To treat these conditions necessarily requires a stabilizing-type apparatus in order to stabilize the ankle area, talocalcaneal, midtarsal, and subtalar joints so that medial and lateral stability of the foot is achieved with the result that the patient enjoys the benefits of greater mobility.
To compensate for the above stated conditions, a person so afflicted must either compensate for it by purchasing a shoe or shoes that can be many sizes larger than they would normally require, resulting in an awkward appearance and an uncomfortable fit. Furthermore, if the individual has an ailment that affects only one foot, he or she must purchase multiple pairs of shoes in order to get a matching set. One set must be purchased in order to get a shoe that fits the unaffected foot, and the larger matching set to get a shoe that fits the afflicted foot, resulting in a pair of shoes costing at least double what would ordinarily be paid. Alternately, the afflicted individual may try to correct the condition by the use of mechanical devices such as braces which attempt to stabilize the foot so that the heel is more aligned with the bones in the lower leg. Generally, the braces used for these types of ailments are large, thick, and cumbersome, which make them inconvenient to use, awkward in appearance and awkward in fit, and often resulting in sores. Thus there exists a need in treating the above mentioned conditions of the feet for a therapeutic foot brace that overcomes such disadvantages.
A primary object of the present invention is to fulfill the above-mentioned needs by the provision of a custom ankle brace system overcoming the above-stated problems. A further primary object of the present invention is to provide such an ankle brace system which is efficient and permits the patient to wear essentially normal shoes. In addition, it is a primary object of this invention to provide such a custom ankle brace system in connection with, and making use of, a novel custom ankle brace. Other objects of this invention will become apparent with reference to the following invention descriptions.
According to a preferred embodiment of the present invention, this invention provides an ankle brace system, for orthotic assistance to an ankle of a patient and adapted to be worn inside a shoe, comprising the steps of: placing a thin flexible stocking-like covering over such ankle of such patient; making markings on such covering on its outside surface to indicate the specific geometry of orthotic support necessary for such ankle, such markings being done in such manner as to be information-transferable to a negative cast overlaying such covering; with the patient""s sole placed in about a horizontal plane and lower leg placed vertically, making a negative cast overlaying such covering; removing such negative cast from such ankle of such patient; such markings being selected from a standard identified group knowable to both the castmaker and the bracemaker, and done in such manner as to include marking information at least relating to a preferred geometry of positive cast build-up for use in making an ankle brace for such patient; and removing such covering from inside such negative cast, whereby such markings remain on an inside surface of such negative cast.
Moreover, this invention provides such an ankle brace system further comprising the steps of: making a positive cast from such negative cast in such manner that such markings are information-transferable to an outside surface of such positive cast; whereby such markings remain on such outside surface of such positive cast; and using such marking information, modifying such positive cast in such manner as to make such positive cast build-up for use in making such ankle brace for such patient. It also provides such an ankle brace system wherein such step of modifying such positive cast comprises the steps of: setting nails in such positive cast, the location and geometry of such nails being structured and arranged so that nailheads of such nails conform to such positive cast build-up; applying additional positive cast material to make such positive cast build-up; and smoothening such positive cast build-up.
Furthermore, this invention provides such an ankle brace system further comprising the steps of: using such positive cast, making a support brace pattern having a single vertical seam on the heel side; making material layers to fit such support brace pattern; and making a stiffener element for use within such material layers in making such ankle brace for such patient; wherein such stiffener element is conformable to such positive cast when heated and comprises a partial sole portion and a leg back portion fixed at about a right angle from such partial sole portion. It further provides such an ankle brace system wherein making of such stiffener element comprises the steps of: providing, in a form large enough to enshroud such positive cast, a sheet of polymeric material shapable by vacuum forming when heated; heating such sheet until readily shapable; fully enshrouding such positive cast with such sheet by an air-tight envelopment but for an opening connected to a vacuum source; through such opening, using such vacuum source, creating a negative air pressure within such sheet sufficient to cause such sheet to conform to the shape of such positive cast; maintaining such negative air pressure until such sheet cools sufficiently to stiffen to such shape of such positive cast, thereby providing a shaped element; removing such shaped element from such positive cast; and trimming such shaped element in such manner as to provide such stiffener element.
Additionally, this invention provides such an ankle brace system wherein such making of such stiffener element further comprises the steps of: providing, in a form sufficient to provide extra stiffening to a side of such ankle of such patient opposed to the arch side, a support segment of such polymeric material; heating such support segment until readily shapable; and, between such step of fully enshrouding and such step of creating a negative air pressure, placing such heated support segment into appropriate position on such sheet in such manner as to contact bond to such sheet. And it also provides such an ankle brace system further comprising the step of, using such pattern, making a resilient element for use within such material layers in making such ankle brace for such patient. It further provides such an ankle brace system further comprising the step of, upon such positive cast, assembling some such material layers (after sewing of such single vertical seam) and such stiffener element, thereby providing a partially-made such ankle brace. And it provides such an ankle brace system further comprising the step of providing an arch support in such stiffener element if and as indicated by such marking information.
Even additionally, this invention provides an ankle brace system further comprising the steps of: trimming such partially-made ankle brace according to such marking information for such patient; and applying a such material layer for use as an outer material layer of such ankle brace; and, further, comprising the steps of removing such partially-made ankle brace from such positive cast, and performing final trimming, stitching, and installing of brace closure elements.
Yet further, in accordance with a preferred embodiment thereof, this invention provides an ankle brace system comprising an ankle brace, for providing orthotic assistance to an ankle area of a patient wherein such ankle area includes at least one abnormal protrusion enhancing disability for normal walking, such ankle brace comprising: multiple adhesively-connected material layers forming overall a toeless boot and shaped to provide room for and support for the abnormal protrusion; and at least one such material layer comprising a stiffener element comprising a partial sole portion lying essentially in a horizontal plane, and an essentially vertical sides-and-back-of-leg portion fixed at about a right angle from such plane of such partial sole portion; such ankle brace being constructed and arranged to be worn by the patient with an essentially normal shoe. And it provides such an ankle brace system wherein at least one of such material layers comprises a foam cushioning material; and, further, wherein such foam cushioning material comprises about a xe2x85x9-inch thick, single density, medical grade polyurethane foam. It also provides such an ankle brace system wherein such stiffener element comprises a polymeric material shapable when heated; and, further, wherein such polymeric material comprises about a 2-millimeter-thick orthopedic grade polymer blend which is auto-adhesive when appropriately heated. And it provides such an ankle brace system wherein the innermost layer of such multiple adhesively-connected material layers comprises a leather material; and, further, wherein such innermost layer comprises 2xc2xd ounce orthopedic tanned leather material. It further provides such an ankle brace system wherein the outermost layer of such multiple adhesively-connected material layers comprises a leather; and, further, wherein such outermost layer comprises a 2xc2xd ounce chromium tanned cowhide leather. And it provides such an ankle brace system wherein such ankle brace further comprises closure elements for tightening and closing such ankle brace on such patient; and, further, wherein such stiffener element does not have a heel portion.
Yet moreover, in accordance with a preferred embodiment thereof, this invention provides an ankle brace system for making, using a positive cast of the foot and lower leg of a patient, an ankle brace, for providing orthotic assistance to an ankle area of a patient, wherein such ankle area includes at least one abnormal protrusion enhancing disability for normal walking, and adapted to be worn inside a shoe, comprising the steps of: making a build-up of such positive cast in the area of such protrusion, sufficient to provide for patient comfort without loss of support; using such positive cast, making a support brace pattern having a single vertical seam on the heel side; making material layers to fit such support brace pattern; and making a stiffener element for use within such material layers in making such ankle brace for such patient; wherein such stiffener element is conformable to such positive cast when heated and comprises a partial sole portion and a leg back portion fixed at about a right angle from such partial sole portion. It also provides such an ankle brace system wherein making of such stiffener element comprises the steps of: providing, in a form large enough to enshroud such positive cast, a sheet of polymeric material shapable by vacuum forming when heated; heating such sheet until readily shapable; placing a talcum-powdered nylon material completely over such positive cast in such manner as to prevent such sheet from sticking to such positive cast; fully enshrouding such positive cast with such sheet by an air-tight envelopment but for an opening connected to a vacuum source; through such opening, using such vacuum source, creating a negative air pressure within such sheet sufficient to cause such sheet to conform to the shape of such positive cast; maintaining such negative air pressure until such sheet cools sufficiently to stiffen to such shape of such positive cast, thereby providing a shaped element; removing such shaped element from such positive cast; and trimming such shaped element in such manner as to provide such stiffener element.
Even additionally, this invention provides such an ankle brace system wherein such making of such stiffener element further comprises the steps of: providing, in a form sufficient to provide extra stiffening to a side of such ankle of such patient opposed to the arch side, a support segment of such polymeric material; heating such support segment until readily shapable; and, between such step of fully enshrouding and such step of creating a negative air pressure, placing such heated support segment into appropriate position on such sheet in such manner as to contact bond to such sheet. It also provides such an ankle brace system further comprising the step of: upon such positive cast, assembling some such material layers (after sewing of such single vertical seam) and such stiffener element, thereby providing a partially-made such ankle brace. And it provides such an ankle brace system wherein such stiffener element is conformed in shape to such positive cast by the application of sufficient heat and pressure to such stiffener element, while such stiffener element is upon such positive cast, to conform the shape of the inside of such stiffener element to the shape of the outside of such positive cast. And it also provides such an ankle brace system further comprising the steps of: removing such partially-made ankle brace from such positive cast; and performing final trimming, stitching, and installing of brace closure elements.